Duns Number:439240722
Device Description: The OT Equator is designed as an endosseous dental implant retentive component used to ret The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
Catalog Number
002CLG435R
Brand Name
SPHERO BLOCK NORMO
Version/Model Number
S/BLOCK N CONELOG ø 4,3 h.5 TiN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
c9d21eda-afae-46bf-a827-4a4a9a96217f
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |